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Home Industry News Pharmaceutical FDA Starts Approval Process for Orexo’s Opioid Treatment
opioid

FDA Starts Approval Process for Orexo’s Opioid Treatment

29th November 2023

Orexo’s new opioid overdose treatment application has been approved for evaluation by the US Food and Drug Administration. 

Containing a substantial amount of naloxone, the treatment labelled OX124, utilizes the company’s powder administration method and is formulated to counteract the impacts of opioids.  

Results from research trials indicated that OX124 provided faster, and more effective opioid absorption, when compared to current injection-based treatments.  

With rapid absorption and elevated bioavailability characteristics, the medication has the potential to effectively counteract an overdose or enable individuals to remain responsive following the use of synthetic opioids.  

Head of Orexo, Nikolaj Sørensen, commented, “I am pleased the FDA can now start reviewing our rescue drug, OX124.” 

Sørensen went on to add, “With its high dose of naloxone and unique formulation, OX124 has the potential to reduce the acceleration in fatal overdoses caused by the widespread misuse of synthetic opioids.” 

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